MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY; CATHETER,INTRAVASCULAR,THE

Model Number 4251687-02

Device Problems Fail-Safe Problem (2936); Device Handling Problem (3265)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by the user facility: a nurse was stuck by one of the iv needles after the safety mechanism had been activated.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: INTROCAN SAFETY
• Type of Device: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 11215083
• MDR Text Key: 240738672
• Report Number: 9610825-2021-00001
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046963165987
• UDI-Public: (01)04046963165987
• Combination Product (y/n): N
• PMA/PMN Number: K020785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4251687-02
• Device Catalogue Number: 4251687-02
• Device Lot Number: 20F27G8393
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1